Fixed dose artesunate amodiaquine – A phase IIb, randomized comparative trial with non-fixed artesunate amodiaquine

by Ogutu B, Juma E, Obonyo C, Jullien V, Carn G, Vaillant M, Taylor WRJ, Kiechel JR. Malaria Journal 2014, doi:10.1186/1475-2875-13-498.

Summary: As part of the development of a fixed dose combination of ASAQ, a pharmacokinetic (PK) and safety study was performed comparing the fixed and loose combinations to complement existing population PK data and explore PK and pharmacodynamic relationships. Tolerability of both formulations was good. For QTcB, a parameter for ECG modifications, increases were modest and due to rising DAQ concentrations and falling heart rates as malaria resolved. Rapid parasite clearance rates and no resistant infections suggest effective pharmacokinetics of both formulations.

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